Adding Heat Treatment to Chemotherapy and Radiotherapy for Advanced Pancreatic Cancer
Tests adding deep regional hyperthermia to usual treatment in locally advanced pancreatic cancer.
Key facts
- Who runs it
- Fernando Pessoa Canarias University
- Where
- Las Palmas de Gran Canaria and Málaga, SpainSee the 2 sites
- Trial code
- Registry title
- A Prospective Study of Concurrent Hyperthermia, Chemotherapy and Radiotherapy in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)
- Status
- Not yet recruiting
- People taking part
- 60 people, planned
- Starts
- 31 Mar 2027
- Expected to end
- 31 Mar 2032
- Type of study
- Interventional
- Treatments tested
- Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp
- Record updated
- 24 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with borderline or locally advanced pancreatic cancer (ductal adenocarcinoma) confirmed by biopsy or cell test, who are in fairly good physical shape.
- Age
- 18 to 80 years
- Sex
- Men and women
- Disease stage
- Borderline or locally advanced ductal adenocarcinoma of the pancreas, proven by biopsy or cytology. No distant metastasis or gross peritoneal carcinomatosis.
- Earlier treatment
- No earlier or current other cancer is allowed. A metal bile duct stent would need to be replaced with a plastic one.
Main reasons for not taking part
- Other cancer in the past or at the same time
- Metal implants, pacemakers or clustered markers
- Heart attack in the past 12 months
- Grade 2 peripheral neuropathy already present
- Pregnancy, breastfeeding or no reliable contraception
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Patients of borderline or Locally advanced pancreatic cancer
- Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy/cytology)
- ECOG performance scale 0 and 1
- Age between 18 and 80 years
- Adequate kidney functionality defined as creatinine clearance >50 ml/min
- Adequate liver functionality defined as total bilirubin ≤2 times of the upper limit of normal
- Adequate bone marrow reserves: WBC count ≥2.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin ≥8.0 g/L
- Women of child-bearing age must secure sufficient contraception control (dual protection with condoms and pills) during the clinical trial and 6 months after the clinical trial is completed
- For females of child bearing potential, pregnancy test within 2 week prior to randomization should be negative
- Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule
Who cannot take part
- Prior or concurrent malignancies
- Patients having metal implants, pacemakers or clustered markers
- Any history of myocardial infarction within the past 12 months
- Any connective tissue disorder that contraindicate RT, e.g., scleroderma
- Any known contraindication or hypersensitivity to the chemotherapeutic agents used in the study as decided by the medical oncologists
- Any other disease or therapy, which, according to the investigator, present a risk to the patient or which are not compatible with the aims of the clinical trial
- Absence of distant metastasis or gross peritoneal carcinomatosis
- Patients with metallic endobiliary stent would need to be replaced with plastic stents
- Pre-existing grade 2 peripheral neuropathy
- Pregnancy, lactation period or lack of reliable contraception
- Indications that the person concerned will possibly not keep to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments
- -
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Spain
- Hospital Universitario de Gran Canaria Dr NegrínLas Palmas de Gran Canaria, SpainContact: Laura Ferrera-Alayón, MD, PhdNo longer taking part
- Hospital Universitario Quirón SaludMálaga, SpainContact: Jorge Contreras, MD, PhDNo longer taking part
About the trial
What the trial wants to find out
The project proposes a prospective multicenter study to evaluate the incorporation of deep regional hyperthermia into the standard of care neoadjuvant chemotherapy (mFOLFIRINOX/NABPACLITAXEL) followed by radiotherapy in borderline and locally advanced ductal adenocarcinoma pancreatic cancer. Although current treatments, based on induction chemotherapy followed by surgery or radiotherapy in selected patients, have improved survival and resection rates, overall survival remains poor.
Read full original descriptionShow less
Hyperthermia is a therapeutic intensification strategy with a solid biological basis. By controlling tumor heating (39-43°C), it enhances the efficacy of chemotherapy and radiation therapy by improving tumor oxygenation, increasing perfusion, and inhibiting DNA damage repair, without adding significant systemic toxicity. The available clinical evidence, although based mainly on retrospective and small studies, suggests that the combination of HRP with multimodal treatments improves local control, favors conversion to surgery, and may prolong survival while maintaining a favorable safety profile.
The protocol contemplates the initial administration of induction chemotherapy (preferably mFOLFIRINOX or, alternatively, gemcitabine with nab-paclitaxel)plus hyperthermia followed by multidisciplinary reevaluation. Patients who deemed resectable will undergo surgery and adjuvant chemoradiotherapy and hyperthermia. Patients without metastatic progression who remain unresectable will receive SBRT in five fractions along with sessions of deep regional hyperthermia. Subsequently, the possibility of surgery will be assessed again and a standardized follow-up will be carried out with clinical, radiological, biochemical and pathological evaluation when appropriate.
The main objective of the study is to determine the impact of this strategy on overall survival. Secondary objectives will be to evaluate progression-free survival, local control, conversion rate to surgery, proportion of R0 resections, tumor response, safety, tolerability, and feasibility of treatment. With this, the study aims to provide prospective evidence on the role of hyperthermia as a therapeutic intensification strategy in localized pancreatic cancer.
The group in the trial
- Hyperthermia plus neoadjuvant chemotherapy/radiotherapyTreatment being tested
Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT
Treatment: Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Study of Concurrent Hyperthermia Plus Standard of Care in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)
- Plain-language title
- Adding Heat Treatment to Chemotherapy and Radiotherapy for Advanced Pancreatic CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07839676, who can take part
- Record updated
- 24 September 2026